Allergic Rhinitis Due to AllergensPhase 3HILARIANCT04729517
Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients
A Phase 3 study testing AI201901 and Azelastine Hydrochloride in people with Allergic Rhinitis Due to Allergens, run by Abdi Ibrahim Ilac San. ve Tic A.S. at 1 site in Turkey (Türkiye).
Trial summary
This is a prospective, national, randomized, multicenter, parallel group, Phase III study that evaluates the effects of AI201901 in Allergic Rhinitis patients, where they will spray twice a day against azelastine into both nostrils during a 28-day follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis Due to Allergens
- What is being tested?
- AI201901 and Azelastine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2021to 2 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be diagnosed as allergic rhinitis on the basis of medical history, physical examination, and skin prick test, and according to ARIA 2008 criteria
- To be included in seasonal and perennial allergic rhinitis group
- To have a related complaint for at least 2 years
- To be informed about the study and to give consent to participate in the study
Who cannot join
- Diagnosis of superficial nasal mucosal erosion, moderate nasal mucosal erosion, nasal mucosal ulceration and nasal septum perforation during nasal examination
- Presence of nasal diseases that are likely to affect the accumulation of intranasal drugs, such as acute or chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis or clinically significant nasal structural abnormalities
- Having undergone a nasal or sinus surgery for up to one year before the study
- The use of systemic or topical steroids within the last 15 days prior to inclusion in the study
- The use of antihistamine, chromoline Na within the last 15 days prior to inclusion in the study
- The use of any investigational drug within 30 days prior to Visit 1;
Show all 25Show fewer
- Known hypersensitivity to components of the products used in the study
- Presence of respiratory infections, which have developed within the two weeks prior to Visit 1
- Diagnosis of COPD
- A history of alcohol or drug addiction treatment within the last 2 years prior to inclusion in the study, or any current addiction on alcohol or drugs,
- Use of alcohol and other drugs (antidepressants) that have a negative effect on reaction time / concurrent use of sedative drugs or other drugs that act on the central nervous system
- Presence of significant lung diseases including asthma. ((Only patients with intermittent asthma who need short-acting inhaled bronchodilators (no more than twice a week) and do not wake up at night due to asthma are suitable for inclusion)).
- Presence of chronic obstructive sleep-apnea syndrome (clinical diagnosis)
- Presence of any surgical or medical condition, which, according to the opinion of the responsible researcher, could significantly alter the absorption, distribution, metabolism, or excretion of the investigational product, or could significantly affect the patient's ability to complete this study
- Presence of symptoms in the medical history in relation to glaucoma, cataract, ocular herpes simplex, conjunctivitis, or other ocular infections
- Presence of medical history in relation to active or latent tuberculosis
- Presence or risk of exposure to chickenpox or measles within the last 30 days
- Presence of untreated fungi, bacteria or systemic viral infection within the last 30 days
- Being pregnant or breastfeeding
- Women of reproductive age who do not use a medically valid contraceptive method
- Presence of cystic fibrosis
- Presence of primary ciliary dyskinesia
- Use of intranasal or systemic first-generation antihistamines, leukotriene receptor antagonists or other nasal decongestants during the study
- Use of any ophthalmic steroid or nasal, inhaled or systemic steroid during the study
- Use of another clinical research product during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Multicenter Phase III Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients (HILARIA)
This is a prospective, national, randomized, multicenter, parallel group, Phase III study that evaluates the effects of AI201901 in Allergic Rhinitis patients, where they will spray twice a day against azelastine into both nostrils during a 28-day follow-up period.
- Conditions
- Allergic Rhinitis Due to Allergens
- Being tested
- AI201901, Azelastine Hydrochloride
- Keywords
- Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI201901Drug
Twice daily inhaled AI201901 for 4 weeks
Azelastine HydrochlorideDrug
Also called Allergodil
Twice daily inhaled Azelastine Hydrochloride for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Azelastine Hydrochloride | Active comparator | Patients that will receive azelastine hydrochloride are defined as the active control arm. Receives: Drug: Azelastine Hydrochloride |
| AI201901 | Experimental | Patients that will receive AI201901 are defined as the test arm. Receives: Drug: AI201901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score
Achieve a statistically significant improvement in the symptoms of allergic rhinitis via Total Nasal Symptom Score (TNSS).
Measured: 28 days
Secondary outcomes (7)
TNNSS; Total non nasal symptom score
In non-nasal symptom scores (TNNSS), AI201901 is similar compared to azelastine
Measured: 28 days
The rhinoconjunctivitis quality of life scale (RQLQ)
The rhinoconjunctivitis quality of life scale (RQLQ) indicates that AI201901 is similar compared to azelastine
Measured: 28 days
Odor Visual Analogue Score (VAS)
In Odor Visual Analogue Score (VAS) results, AI201901 is better than azelastine
Measured: 28 days
Inspiratory peak flow meter (PNIF)
Inspiratory peak flow meter (PNIF) results show that AI201901 is similar compared to azelastine
Measured: 28 days
Connecticut butanol odor threshold test
Connecticut butanol odor threshold tests show that AI201901 is similar compared to azelastine
Measured: 28 days
Rhinoscopic Assessment Scale
Results of the Rhinoscopic Assessment Scale show that AI201901 is better than azelastine
Measured: 28 days
Safety of AI201901
Demonstration of the safety of AI201901 by comparing the number of participants with treatment-related adverse events in each arm.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start20 Apr 2021
- Primary completion3 Mar 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to AllergensStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first group will receive AI201901 , whereas the second group will receive azelastine hydrochloride. Patients that will receive AI201901 are defined as the test arm and patients that will receive azelastine hydrochloride are defined as the active control arm.
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdi Ibrahim Ilac San. ve Tic A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Umraniye Education and Research Hospital, Diskapi Yildirim Beyazit Education and Research Hospital, Antalya Training and Research Hospital, Dokuz Eylul University, Ankara City Hospital Bilkent, Kahramanmaras Sutcu Imam University, Uludag University, Karadeniz Technical University, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729517
- Sponsor's protocol ID
- Aİ-2019-01
- Acronym
- HILARIA
- Status last verified
- Aug 2022
- First submitted
- 20 Jan 2021
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Phase III Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients (HILARIA)
- ClinicalTrials.gov ID
- NCT04729517
- Acronym / sponsor ID
- HILARIA / Aİ-2019-01
- Conditions
- Allergic Rhinitis Due to Allergens
- Keywords
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Abdi Ibrahim Ilac San. ve Tic A.S.Industry (pharma, biotech, devices)
- Collaborators
- Umraniye Education and Research Hospital, Diskapi Yildirim Beyazit Education and Research Hospital, Antalya Training and Research Hospital, Dokuz Eylul University, Ankara City Hospital Bilkent, Kahramanmaras Sutcu Imam University, Uludag University, Karadeniz Technical University, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, national, randomized, multicenter, parallel group, Phase III study that evaluates the effects of AI201901 in Allergic Rhinitis patients, where they will spray twice a day against azelastine into both nostrils during a 28-day follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first group will receive AI201901 , whereas the second group will receive azelastine hydrochloride. Patients that will receive AI201901 are defined as the test arm and patients that will receive azelastine hydrochloride are defined as the active control arm.
| Arm | Type | Receives |
|---|---|---|
| Azelastine Hydrochloride | Active comparator | Drug: Azelastine HydrochloridePatients that will receive azelastine hydrochloride are defined as the active control arm. |
| AI201901 | Experimental | Drug: AI201901Patients that will receive AI201901 are defined as the test arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be diagnosed as allergic rhinitis on the basis of medical history, physical examination, and skin prick test, and according to ARIA 2008 criteria
- To be included in seasonal and perennial allergic rhinitis group
- To have a related complaint for at least 2 years
- To be informed about the study and to give consent to participate in the study
Key exclusion criteria (25 listed)
- Diagnosis of superficial nasal mucosal erosion, moderate nasal mucosal erosion, nasal mucosal ulceration and nasal septum perforation during nasal examination
- Presence of nasal diseases that are likely to affect the accumulation of intranasal drugs, such as acute or chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis or clinically significant nasal structural abnormalities
- Having undergone a nasal or sinus surgery for up to one year before the study
- The use of systemic or topical steroids within the last 15 days prior to inclusion in the study
- The use of antihistamine, chromoline Na within the last 15 days prior to inclusion in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI201901Twice daily inhaled AI201901 for 4 weeks | Drug | AI201901 |
| Azelastine HydrochlorideAlso: AllergodilTwice daily inhaled Azelastine Hydrochloride for 4 weeks | Drug | Azelastine Hydrochloride |
Primary outcome
Total Nasal Symptom Score
Time frame: 28 days
Achieve a statistically significant improvement in the symptoms of allergic rhinitis via Total Nasal Symptom Score (TNSS).
7 secondary outcomes
TNNSS; Total non nasal symptom score
Time frame: 28 days
The rhinoconjunctivitis quality of life scale (RQLQ)
Time frame: 28 days
Odor Visual Analogue Score (VAS)
Time frame: 28 days
Inspiratory peak flow meter (PNIF)
Time frame: 28 days
Connecticut butanol odor threshold test
Time frame: 28 days
Rhinoscopic Assessment Scale
Time frame: 28 days
Safety of AI201901
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
Related trials for Allergic Rhinitis Due to Allergens
Not yet recruitingObservational study
A Study to Identify and Characterize Adults and Pediatric Participants With Cat and/or Birch Allergy
Conjunctivitis Allergic
RecruitingObservational study
The Efficacy of Specific Immunotherapy Guided by Component-Resolved Diagnosis for Dust Mite Allergens in Chinese Pediatric Patients With Rhinitis and/or Asthma
Allergic Rhinitis Due to House Dust Mite
Not yet recruitingObservational study
Noninterventional Study on Tolerability and Safety of One Strength Updosing With Novo-Helisen Depot House Dust Mites
Allergic Rhinitis Due to House Dust Mite, Allergic Conjunctivitis Due to Dermatophagoides Farinae
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AI201901 and Azelastine Hydrochloride in people with Allergic Rhinitis Due to Allergens, run by Abdi Ibrahim Ilac San. ve Tic A.S. at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Nasal Symptom Score (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.